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FDA 510(k)

BracePaste Fluoride Sealant

K-Number: K242537 · 2024-08-27

ApplicantAmerican Orthodontics Corp.
Decision Date2024-08-27
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BracePaste Fluoride Sealant is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics Corp.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K242537. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BracePaste Fluoride Sealant?

BracePaste Fluoride Sealant is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is American Orthodontics Corp.. The 510(k) number is K242537.

When did BracePaste Fluoride Sealant receive FDA 510(k) clearance?

BracePaste Fluoride Sealant received FDA 510(k) clearance on 2024-08-27, under 510(k) number K242537.

Who is the listed applicant for BracePaste Fluoride Sealant?

The FDA 510(k) record lists American Orthodontics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BracePaste Fluoride Sealant?

The FDA product code for BracePaste Fluoride Sealant is DYH.

Other records listing American Orthodontics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261840BracePaste Prime PlusK232011CleoK202276BracePaste Band and Build LCK181910BracePaste MTP Light Cure PrimerK172953Acid EtchantK160782BracePaste Adhesive

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Related Devices (Code: DYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbHK214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520Tp Orthodontics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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